Clexane Forte Side Effects

Note: This page contains information about the side effects of enoxaparin. Some of the dosage forms included on this document may not apply to the brand name Clexane Forte.

Not all side effects for Clexane Forte may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to enoxaparin: injectable, solution

In addition to its needed effects, some unwanted effects may be caused by enoxaparin (the active ingredient contained in Clexane Forte). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking enoxaparin:

More common

Bleeding gums

coughing up blood

difficulty with breathing or swallowing

dizziness

headache

increased menstrual flow or vaginal bleeding

nosebleeds

paralysis

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

shortness of breath

Less common

Bruising

chest discomfort

collection of blood under the skin

confusion

continuing bleeding or oozing from the nose and/or mouth, or surgical wound

convulsions (seizures)

fever

irritability

lightheadedness

lower back pain

pain or burning while urinating

swelling of the hands or feet

tightness in the chest

uncontrolled bleeding at the site of injection

vomiting of blood or material that looks like coffee grounds

wheezing

Rare

Back pain

burning, pricking, tickling, or tingling sensation

chest pain

chills

cough

decreased urine output

dilated neck veins

dizziness or lightheadedness when getting up suddenly from a lying or sitting position

extreme fatigue

fainting

fast or irregular heartbeat

general feeling of discomfort or illness

irregular breathing

leg weakness

problems with bowel or bladder function

skin rash or hives

sneezing

sore throat

sudden fainting

swelling of the face, fingers, feet, genitals, mouth, or tongue

thickening of the bronchial secretions

troubled breathing

weight gain

Incidence not known

Abdominal or stomach pain

deep, dark purple bruise

hives or welts

irregular heartbeat

itching, pain, redness, or swelling

large, flat, blue, or purplish patches in the skin

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

skin rash

unusual tiredness or weakness

weakness or heaviness of the legs

Some of the side effects that can occur with enoxaparin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Patients undergoing spinal/epidural anesthesia or puncture and anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk for long-term or permanent paralysis due to epidural or spinal hematoma. The risk of these events is increased by the use of indwelling epidural catheters or by concomitant use of platelet inhibitors, other anticoagulants, or drugs that affect hemostasis.

In one clinical study, compared with younger patients, the incidence of bleeding complications was higher in patients greater than or equal to 65-years-old.

Patients previously exposed to unfractionated heparin or a low-molecular-weight heparin appear to be more susceptible to developing heparin-induced thrombocytopenia (HIT) and HIT-related thromboembolic complications (e.g., transient ischemic attack, stroke) than those who were never exposed.

Heparin-induced thrombocytopenia (HIT) is an immune-mediated, prothrombotic reaction that occurs in 0.5% to 5% of patients treated with unfractionated heparin and in less than 1% of patients treated with a low molecular weight heparin (LMWH). The decrease in platelet count associated with HIT usually begins 5 to 14 days after starting heparin. However, patients with a previous exposure to heparin may have an abrupt decrease in platelets upon restarting heparin. Patients with LMWH-induced HIT exhibit a longer delay in the onset of symptoms compared with those who develop it from unfractionated heparin. Following discontinuation, platelet counts begin to recover within 4 days, but may take more than 2 weeks in patients with high-titer HIT antibodies. Thrombocytopenia is caused by heparin-dependent IgG antibodies that bind to a specific platelet protein, platelet factor 4 (PF4). The heparin-PF4-IgG immune complex binds to platelets causing platelet activation. The activated platelets cause release of platelet-derived procoagulant microparticles, which accelerate coagulation reactions and generate thrombin. LMWHs have a high cross-reactivity with circulating heparin-PF4-IgG immune complex. Factors associated with a higher risk for developing HIT-associated thrombosis include women, nonwhites, severity of thrombocytopenia, and lower body weight. Complications associated with HIT include exacerbation of venous thromboembolism, arterial or venous thrombosis, limb gangrene, stroke, and skin necrosis. The antibodies that cause HIT will usually disappear after approximately 3 months; therefore, use of unfractionated heparin or LMWH may be considered in a patient with a history of HIT if the antibody test is negative.

Factors associated with an increased risk of bleeding include high doses, advanced age, renal dysfunction, and concomitant use of other drugs that affect hemostasis.[Ref]

Hepatic

Hepatic side effects have included transient elevations in liver function tests. Postmarketing side effects have included hepatocellular and cholestatic liver injury.[Ref]

Local

Local side effects have included pain, erythema, ecchymosis, and hematoma. Rarely, painful, red induration and necrotic ulcerations at the injection site have been reported. Skin necrosis distant from the injection site has also been reported.[Ref]

Skin necrosis occasionally accompanies heparin-associated thrombocytopenia and thrombosis syndrome. This complication is thought to occur less with enoxaparin than with unfractionated heparin. However, a recent report noted the occurrence of skin necrosis and associated thrombocytopenia with low molecular weight heparin use. If late-onset skin necrosis, thrombocytopenia, and/or thromboembolism occur during use, immediate discontinuation of low-molecular weight heparin is mandatory in order to avoid potentially fatal thromboembolic complications.[Ref]

Hypersensitivity

Hypersensitivity side effects including systemic allergic reactions, pruritus, urticaria, and anaphylactic/anaphylactoid reactions including shock have been reported in postmarketing experience. A case of angioedema has been reported.[Ref]

Dermatologic

Dermatologic side effects have included vesiculobullous rash, purpura, and cutaneous vasculitis. At least two cases of bullous pemphigoid-like eruption and one rare case of enoxaparin-induced ischemic skin necrosis have been reported. Postmarketing side effects have included alopecia.[Ref]

Respiratory

Respiratory side effects have included lung edema, pneumonia, and dyspnea.[Ref]

Cardiovascular

Cardiovascular side effects have included atrial fibrillation, heart failure, edema, and peripheral edema.[Ref]

Gastrointestinal

Metabolic

Metabolic side effects have rarely included hyperlipidemia. Postmarketing reports have included cases of hyperkalemia. Most of these reports occurred in patients who also had conditions that tend toward the development of hyperkalemia (e.g., renal dysfunction, concomitant potassium-sparing drugs, administration of potassium, and hematoma in body tissues).[Ref]

One case of hyperlipidemia with marked hypertriglyceridemia was reported in a diabetic pregnant woman, although causality has not been determined.[Ref]

Genitourinary

Genitourinary side effects have included hematuria.

Nervous system

Nervous system side effects have included confusion and postmarketing reports of headache.

Other

General

In general, hemorrhagic side effects have occurred in 3% to 7% of patients. A meta-analysis of published studies reported an overall incidence of major bleeding with low molecular weight heparins of 0.7% to 1.4%. Hemorrhage may occur at any site in the body.[Ref]

Any unexplained decrease in blood pressure and/or hematocrit as well as unexplained symptoms should prompt consideration of a possible hemorrhagic event.[Ref]

Musculoskeletal

In a study involving pregnant women (n=120) requiring thromboprophylaxis, clinically significant bone loss (i.e., 10% or greater) in the femur occurred in approximately 2% to 2.5% of patients regardless if they received enoxaparin (the active ingredient contained in Clexane Forte) (68.4 mg/day) or unfractionated heparin (17,380 units/day) for approximately 26 to 27 weeks.[Ref]

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